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| |  FDA Approves Cipro (Ciprofloxacin) For Post-Exposure Inhalational Anthrax WEST HAVEN, CT -- August 31, 2000 -- The U.S. Food and Drug Administration (FDA) has approved Cipro® (ciprofloxacin) for post-exposure inhalational anthrax. This type of exposure would most likely occur during a bioterrorist attack. This indication was granted under provisions of accelerated approval, on the basis of blood levels achieved in humans and the results of in vitro and animal testing. Since its introduction in 1987, Cipro, made by Bayer Corporation, has been extensively studied and is the most widely used fluoroquinolone antibiotic in the world. It has a proven track record of efficacy and safety and has been prescribed more than 250 million times. Cipro is now approved for 14 different uses including respiratory and urinary tract infections. "We recognize the government's need to be prepared for a biological attack and we are pleased that Cipro can play an important role in the preparedness plan," said Carl Calcagni, Vice President of Regulatory Affairs for Bayer. Inhalational anthrax is usually fatal. In order to be effective, Cipro administration should begin as soon as possible after anthrax exposure and before symptoms appear. The recommended duration of Cipro administration is 60 days. On July 28, an FDA advisory panel unanimously recommended approval after listening to expert testimony, which included results of an animal study conducted by the Department of Defense. Although penicillin and doxycycline are FDA approved to treat anthrax, they are not specifically indicated for inhalational anthrax (post-exposure). In addition, there are reports indicating that strains of the bacteria have been engineered to resist penicillin and doxycycline. Early administration of ciprofloxacin or other fluoroquinolones has been recommended by The Working Group on Civilian Biodefense(1). The U.S. Army and the Centers for Disease Control and Prevention have also recommended Cipro as a drug of choice for inhalational anthrax (post-exposure). Cipro Tablets, Cipro Oral Suspension, and Cipro IV are indicated for the treatment of infections caused by susceptible strains of indicated organisms in the following conditions: acute sinusitis; lower respiratory tract infections; nosocomial pneumonia (I.V. only); urinary tract infections; acute uncomplicated cystitis in females (Tablets and Oral Suspension only); chronic bacterial prostatitis; complicated intra-abdominal infections (in combination with metronidazole); skin and skin structure infections; bone and joint infections; and infectious diarrhea, typhoid fever (enteric fever); uncomplicated cervical and urethral gonorrhea (Tablets and Oral Suspension only); and inhalational anthrax (post-exposure): To reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Cipro I.V. is also indicated in empirical therapy for febrile neutropenic patients (in combination with piperacillin sodium). Serious and fatal reactions have been reported in patients receiving concurrent administration of ciprofloxacin and theophylline. Monitor theophylline levels if concurrent administration cannot be avoided. The safety and effectiveness of ciprofloxacin in children and adolescents less than 18 years of age, except for inhalational anthrax (post-exposure), pregnant women and lactating women have not been established. Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin or any member of the quinolone class of antimicrobial agents. Ciprofloxacin should be discontinued at the first sign of an allergic reaction. Most frequently reported adverse events (>1 percent) without regard to drug relationship were: -- Cipro Tablets and Oral Suspension: nausea, diarrhea, vomiting, abdominal pain/discomfort, headache, rash, restlessness. Related Link: Cipro (ciprofloxacin).
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